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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K905156
Device Name BIO MEDX AIR FLOTATION SYSTEM
Applicant
Bio Clinic Co.
4083 E. Airport Dr.
Ontario,  CA  91761
Applicant Contact KEITH GILROY
Correspondent
Bio Clinic Co.
4083 E. Airport Dr.
Ontario,  CA  91761
Correspondent Contact KEITH GILROY
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received11/15/1990
Decision Date 11/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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